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Cypress, CA, US
Boldly innovating to create trusted solutions that detect, predict, and prevent disease.
Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care…Join Us Now!
At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and committed to iRhythm’s employees and the mission of the company. We are better together, embrace change and help one another. We are Thinking Bigger and Moving Faster.
Position: Staff Quality Engineer – New Product Introduction (NPI)
Location: 6550 Katella Ave, Cypress, CA, 90630
Responsibilities include:
iRhythm Technologies Inc. is seeking a Staff Quality Engineer – New Product Introduction (NPI) (Cypress, CA) to provide quality engineering support to iRhythm’s development and manufacturing environments with a focus on New Product and Process Introduction. Be involved with new products, site/process expansions, major and minor product and process changes, and strategic manufacturing led projects. Actively participate as the Quality lead for projects. Provide critical engineering and quality driven input towards early phase of new product introductions/projects involving product firmware, non‐product software, hardware, tooling, and systems. Partner with Design Quality Engineering team to ensure successful product transfer into manufacturing. Apply engineering principles and quality regulations to drive validation and qualification strategies and executions during transfer phases for new product introductions and ongoing design control projects for product changes (including reviewing and approving protocols). Actively participate in execution oversite for IQ/OQ/PQs, TMVs, engineering studies, and verifications. Apply general manufacturing practices and design control principles to identify critical design inputs/outputs during NPI implementations. Apply statistical knowledge to complete and analyze datasets, interpret results and provide data driven feedback to design and manufacturing teams. Develop and continuously improve applicable procedures to ensure the compliance with applicable standards and industry practices. Produce technical reports to support quality assurance investigations as needed. Participate as an NPI quality representative to associated risk documentation. Telecommuting permitted up to 2 days per week. Up to 10% international travel required and up to 10% domestic travel required.
SALARY: $137,200 to $154,500 per year
JOB REQUIREMENTS:
The position requires a Bachelor’s degree in Mechanical Engineering, Applied Science, Engineering or a related field of study and eight (8) years of Quality Assurance or Manufacturing of class II/III experience. Experience must involve three (3) years in the following: Design Control. Experience must involve the following: competency with 21 CFR 820, ISO 13485, and ISO
14971; Microsoft Excel, Word, and Visio; root cause analysis; Lean Manufacturing; cross‐functional communication and collaboration; Medical Device process validation; design transfer; addressing technical challenges with creative problem solving techniques; Technical Writing; and validation activity with hardware or software. Up to 10% international travel required and up to 10% domestic travel required.
THIS POSITION IS ELIGIBLE FOR THE EMPLOYEE REFERRAL PROGRAM
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.
iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com
About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.
Make iRhythm your path forward. Zio, the heart monitor that changed the game.
Our salary intelligence, powered by our AI algorithms, has calculated an estimated range for this position between $85,000 - $115,000 . Please note that the actual salary for this position may vary, as it is dependent on various factors including but not limited to experience, location, and market dynamics.